Second quarter 2017 GAAP revenue increased 24% over same period last year IntrarosaTM (prasterone) now commercially available Completed Feraheme® (ferumoxytol) submission to FDA to broaden label beyond chronic kidney disease Conference call scheduled for 8:00 a.m. ET today WALTHAM, Mass., Aug. 03, 2017 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today reported unaudited consolidated financial… More
News Category: Press Releases
Press Releases
AMAG Completes Feraheme® (ferumoxytol) FDA Submission for the Treatment of All Adult Patients With Iron Deficiency Anemia
Filing includes results of head-to-head Phase 3 clinical trial evaluating Feraheme compared to ferric carboxymaltose injection Potential approval and launch in the first half of 2018 WALTHAM, Mass., Aug. 03, 2017 (GLOBE NEWSWIRE) — Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that it has completed the submission to the U.S. Food and Drug Administration (FDA) to broaden… More
AMAG Pharmaceuticals Launches Intrarosa™ (prasterone) in the U.S. – a Novel Product to Treat Moderate to Severe Dyspareunia Due to Menopause
Intrarosa addresses an unmet need for women with moderate to severe dyspareunia, a common symptom of vulvar and vaginal atrophy, due to menopause Launch includes best-in-class copay savings program to help ensure swift and affordable access to Intrarosa for millions of women WALTHAM, Mass., July 24, 2017 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today… More
AMAG Pharmaceuticals to Host Second Quarter 2017 Financial Results Conference Call and Webcast on Thursday, August 3, 2017 at 8:00 a.m. ET
WALTHAM, Mass., July 20, 2017 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that its second quarter 2017 financial results will be released on Thursday, August 3, 2017 before the U.S. financial markets open. Management will host a conference call and webcast at 8:00 a.m. ET to discuss the results and provide an update… More
AMAG Announces U.S. FDA Filing Acceptance of Supplemental New Drug Application for Makena® (hydroxyprogesterone caproate injection) Subcutaneous Auto-Injector
WALTHAM, Mass., June 26, 2017 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) accepted the supplemental new drug application (sNDA) for the Makena® subcutaneous auto-injector, a drug-device combination product. The agency has established a Prescription Drug User Fee Act (PDUFA) target action date of February 14, 2018. The FDA acknowledged that it had previously communicated a… More
AMAG Announces First Patient Enrolled in Phase 2b/3a Digoxin Immune Fab Study Conducted by Velo Bio
WALTHAM, Mass., June 01, 2017 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that Velo Bio, LLC has enrolled the first patient in a Phase 2b/3a study designed to evaluate the efficacy and safety of digoxin immune fab (DIF), a polyclonal antibody in development for the treatment of severe preeclampsia in pregnant women. Following… More
AMAG Pharmaceuticals to Present at Upcoming Investor Conferences
WALTHAM, Mass., May 31, 2017 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that company management will participate in the following investor conferences: Jefferies 2017 Global Healthcare ConferenceTuesday, June 6, 2017 at 9:30 a.m. ETLocation: New York, NY Goldman Sachs Leveraged Finance ConferenceTuesday, June 20, 2017 at 11:20 a.m. PT (2:20 p.m. ET)Location: Palos… More
AMAG Pharmaceuticals Appoints Helen Milton, Ph.D. as Vice President of Regulatory Affairs
WALTHAM, Mass., May 16, 2017 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced the appointment of Helen Milton, Ph.D., to the role of vice president of regulatory affairs. Dr. Milton will have responsibility for AMAG’s regulatory activities, including leading the strategic direction and regulatory approach for all products. She will also oversee the company’s… More
AMAG Pharmaceuticals Completes Financing Transactions in Support of Future Growth Strategy
Transactions extend maturities and reduce total debt by approximately 18% WALTHAM, Mass., May 15, 2017 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) today announced that it has paid in full the remaining balance of $321 million of its term loan, which was due in 2021. This transaction, as well as the recently announced $300 million… More
AMAG Pharmaceuticals to Host Analyst Day on May 24th in New York
WALTHAM, Mass., May 10, 2017 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that it will host an Analyst Day for the investment community on Wednesday, May 24, 2017 from 8:30 a.m. to 12:00 p.m. Eastern Time. Members of AMAG’s management team and industry experts will provide updates on the Company’s pipeline and commercial… More